Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

NCT01571674 | Completed Phase 2 DMC

• 1 other identifier: 12-0040
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation.

Conditions

Shoulder Pain

Keywords

Cervical; Clinical Prediction Rule; Exercise; Manipulation; Manual therapy; Mobilization; Physical Therapy; Prognosis; Shoulder pain; Thoracic

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain and Disability Index (SPADI) Score

  The SPADI is a 13 item questionnaire. The pain domain consists of five questions and the disability domain consists of eight. Each question refers to the past week.

  1 week, 4 weeks, 6 months

Secondary Outcomes (4)

• Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)

  1 week, 4 weeks and 6 months

• Global Rating of Change (GROC)

  1 week, 4 weeks, 6 months

• Change in the Numeric Pain Rating Scale (NPRS)

  1 week, 4 weeks, 6 months

• Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)

  1 week, 4 weeks, 6 months

Study Arms (2)

Manipulation + Exercise Group

EXPERIMENTAL

The treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group.

Procedure: Manipulation + Exercise Group; Procedure: Exercise Group

Exercise Group

ACTIVE COMPARATOR

The exercise group will be treated with a stretching and strengthening program.

Procedure: Exercise Group

Interventions

Manipulation + Exercise Group PROCEDURE

First 2 sessions * High-velocity, low-amplitude manipulations to the thoracic spine. * Low-velocity mid to end-range mobilizations to the cervical spine. * Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program

Manipulation + Exercise Group

Exercise Group PROCEDURE

First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program

Exercise Group; Manipulation + Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram to the right)
• Age between 18-65 years old
• Shoulder Pain and Disability (SPADI) score \> 20 points

You may not qualify if:

• Medical red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• Acute fractures in the shoulder region.
• Acute severe trauma in the cervical or thoracic region in the last 6 weeks.
• Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
• Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
• Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
• Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
• Muscle weakness involving a major muscle group of the upper extremity
• Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes)
• Diminished or absent sensation to pinprick in any upper extremity dermatome
• Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.
• Insufficient English language skills to complete all questionnaires
• Inability to comply with treatment and follow-up schedule

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Virginia Commonwealth University: collaborator
• University of Colorado, Boulder: collaborator
• Northern Navajo Medical Center: collaborator
• Gundersen Lutheran Health System: collaborator
• Waldron's Peak Physical Therapy: collaborator
• Temple University: collaborator

Study Sites (9)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Waldron's Peak Physical Therapy

Boulder, Colorado, 80303, United States

Location

Wardenburg Health Center at the University of Colorado

Boulder, Colorado, 80303, United States

Location

Franklin Pierce University

Concord, New Hampshire, 03461, United States

Location

Northern Navajo Medical Center

Shiprock, New Mexico, 87420, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

VCUHS- Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

University of Puget Sound

Tacoma, Washington, 98416, United States

Location

Gundersen Lutheran

Onalaska, Wisconsin, 54650, United States

Location

Related Publications (10)

• Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.

  PMID: 20599053 BACKGROUND

• Mintken PE, Cleland JA, Carpenter KJ, Bieniek ML, Keirns M, Whitman JM. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010 Jan;90(1):26-42. doi: 10.2522/ptj.20090095. Epub 2009 Dec 3.

  PMID: 19959652 BACKGROUND

• Mintken PE, DeRosa C, Little T, Smith B; American Academy of Orthopaedic Manual Physical Therapists. AAOMPT clinical guidelines: A model for standardizing manipulation terminology in physical therapy practice. J Orthop Sports Phys Ther. 2008 Mar;38(3):A1-6. doi: 10.2519/jospt.2008.0301. Epub 2008 Feb 29.

  PMID: 18349498 BACKGROUND

• Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004 Sep 21;141(6):432-9. doi: 10.7326/0003-4819-141-6-200409210-00008.

  PMID: 15381516 BACKGROUND

• Strunce JB, Walker MJ, Boyles RE, Young BA. The immediate effects of thoracic spine and rib manipulation on subjects with primary complaints of shoulder pain. J Man Manip Ther. 2009;17(4):230-6. doi: 10.1179/106698109791352102.

  PMID: 20140154 BACKGROUND

• Boyles RE, Ritland BM, Miracle BM, Barclay DM, Faul MS, Moore JH, Koppenhaver SL, Wainner RS. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009 Aug;14(4):375-80. doi: 10.1016/j.math.2008.05.005. Epub 2008 Aug 15.

  PMID: 18703377 BACKGROUND

• Walser RF, Meserve BB, Boucher TR. The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials. J Man Manip Ther. 2009;17(4):237-46. doi: 10.1179/106698109791352085.

  PMID: 20140155 BACKGROUND

• Failla MJ, Mintken PE, McDevitt AW, Michener LA. Trajectory of patient-rated outcomes and association with patient acceptable symptom state in patients with musculoskeletal shoulder pain. J Man Manip Ther. 2023 Aug;31(4):279-286. doi: 10.1080/10669817.2022.2137350. Epub 2022 Oct 27.

  PMID: 36300352 DERIVED

• Mintken PE, McDevitt AW, Michener LA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Cleland JA. Examination of the Validity of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation. J Orthop Sports Phys Ther. 2017 Apr;47(4):252-260. doi: 10.2519/jospt.2017.7100. Epub 2017 Mar 3.

  PMID: 28257617 DERIVED

• Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.

  PMID: 27477473 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Paul Mintken, DPT

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 5, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (9)